MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS AUTOMATED ENDSCOPE REPROCESSOR; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

The facility reported an unknown white residue in the basins of their advantage plus automated endoscope reprocessors (aers) and endoscopes.There is potential for patient harm caused by patient exposure to the unknown residual during endoscopic procedures.Medivators field service engineer has visited the facility to evaluate the unit.The fse confirmed the unit is operating according to specification.The facility has been using their aers for about a year and a half but reported the residue was noticed for the first time recently.It is unknown if changes in the processes at the facility have occurred, causing the residue.The facility indicated they will take samples of the residue for analysis but the results have not been reported to medivators.It is unknown if the endoscopes with the white residue have been used during patient procedures.There have been no reports of patient harm.Medivators has contacted the facility but has not received any further information.This complaint will continue to be monitored in the medivators complaint handling system.

Event Description

The facility reported an unknown white residue in the basins of their advantage plus automated endoscope reprocessors (aers).There is potential for patient harm caused by patient exposure to the unknown residual during endoscopic procedures.

• Brand Name: ADVANTAGE PLUS AUTOMATED ENDSCOPE REPROCESSOR
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: sadie martin ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 7307869
• MDR Text Key: 101341870
• Report Number: 2150060-2018-00015
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other